Otc - Active Ingredient
Active ingredients
(in each 5mL teaspoonful)
Brompheniramine Maleate 2 mg
Chlophedianol Hydrochloride 12.5 mg
Pseudoephedrine Hydrochloride 30 mg
Atuss Da
FDA Label NDC 58407-252
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Magna Pharmceuticals, Inc. for the product Atuss Da (NDC 58407-252). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Cough Suppressant
Nasal Decongestant
Indications & Usage
Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- nasal congestion
- reduces swelling of nasal passages
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Warnings
Do not exceed recommended dosage.
Otc - Do Not Use
Do not use this product
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a physician or pharmacist before taking this product.
Otc - Ask Doctor
Ask a physician before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a physician or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - When Using
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Otc - Stop Use
Stop use and ask a physician if
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional befor use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
In case of an accidental overdose, seek professional help or contact a Poison Control Center immediately.
Dosage & Administration
Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over: | 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teapoonfuls (40 mL) in 24 hours. |
Children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours. |
Children under 6 years of age: | Consult a physician |
Storage And Handling
Other information
Store at 59° - 86°F (15° - 30°C)
Inactive Ingredient
Inactive ingredients
Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
Otc - Questions
Questions? Comments?
Call your physician for medical advice. Serious side effects associated with this product may be reported to this number. 1-888-206-5525, 8 am - 5 pm, M-F EST
Other
Manufactured for:
MAGNA
Phamaceuticals, Inc.
Accountability.
Louisvill, KY 40299
magnaweb.com
Rev. 01/18
* Please review the disclaimer below.
